Detection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease (Scope)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Detection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease|
- Groton Maze Learning Test [ Time Frame: 18 Months ] [ Designated as safety issue: No ]Total number of correct moves over 5 trials on the Groton Maze Learning Test at 3 hours
- Groton Maze Learning Test [ Time Frame: 18 Months ] [ Designated as safety issue: No ]Mean number of correct moves per second on the Groton Maze Learning Test at 3 hours
- CogState One-Back Learning (OBK) Task [ Time Frame: 18 Months ] [ Designated as safety issue: No ]Overall performance across study visits.
- 12-Item International Shopping List Test - Immediate and Delayed Recall (CogState) [ Time Frame: 18 Months ] [ Designated as safety issue: No ]Overall performance across study visits.
- Rentz Face-Name Association Test [ Time Frame: 18 Months ] [ Designated as safety issue: No ]Overall performance across study visits.
- Stark Pattern Separation Test [ Time Frame: 18 Months ] [ Designated as safety issue: No ]Overall performance across study visits.
- Minnesota Cognitive Acuity Scale (MCAS) [ Time Frame: Pre-baseline ] [ Designated as safety issue: No ]Screening acuity.
- Saliva Sample for DNA Analyses (ApoE and BDNF genotyping) [ Time Frame: Baseline ] [ Designated as safety issue: No ]Mutation status.
- Non-invasive imaging of macula, retinal function and visual fields [ Time Frame: 18 Months ] [ Designated as safety issue: No ]Change over time.
- CogState Once-Card learning (OCL) Task [ Time Frame: 18 Months ] [ Designated as safety issue: No ]Overall performance across study visits.
- Amyloid and Alzheimer's Psycho-educational Session [ Time Frame: 9 and 18 month study visits ] [ Designated as safety issue: No ]An informational exercise to provide further information about amyloid PET imaging and to determine the impact of this disclosure of study participants.
- Tokyo Subway Navigation [ Time Frame: 9 month follow-up visit ] [ Designated as safety issue: No ]A functional activity of daily living where study participants are given pre-determined destinations / conditions and asked to map the route. Main outcome measure for this assessment is time taken to solve the problem.
- MAC-Q [ Time Frame: Pre-screen, Baseline, 9 & 18 month follow-up ] [ Designated as safety issue: No ]A six-item scale measuring age-related memory decline. An overall index of cognitive decline is calculated by summing scores for all six items with double weighting for item #6. Higher scores indicate greater decline in memory.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Pre-Symptomatic Alzheimers' Disease
Other: Observational Study
We will take pictures of subjects' brains using PET imaging, in healthy older adults (ages 55 to 80 years) who have both a family history of AD, and who have concerns about changes in their memory (but no clinical symptoms of AD), to see how much of a protein - that is related to AD -is in their brains. When all subjects come to the hospital for PET imaging, we will review the entire study plan with them, the risks and benefits of participation, and we will obtain written informed consent at that time. Our goal is to compare performance on our new stress test to these PET imaging results. Once the PET imaging is done, we will have each subject come to our clinical research unit for a day-long baseline visit. In the morning we will give the tests of memory and thinking, and then we will administer the injection of scopolamine at a very low dose. We will then continue to examine the subjects, and to give the memory and thinking tests at 1, 3, 5, 7, and 8 hours post-dosing. Once they have fully-recovered from all effects of the medication, they will be allowed to go home that day. We will then see all subjects again, for much shorter visits to complete the cognitive tests, at both 9 and 18 months after their initial study visit. We will follow all subjects for 18 months to see which of them show very mild but measurable changes on the memory and thinking tests, as we predict that these will be the same persons who also had stronger results on our stress test at the first study visit.
At all three study visits to our clinical research unit, we will obtain measurements using an imaging device that uses infrared and blue light to take picture of the eye and retina. Our secondary goal in this study to search for evidence of the same protein, in the retina, that builds up and is seen with PET imaging of the brain in persons who are at high risk for AD. Finally, we are also collecting a small sample of saliva, at the first visit to our unit, in order to see which subjects have a genetic risk for the disease, as this genetic risk may affect how we interpret the results of our new "cognitive stress test".
In this study, a small dose of an already approved medication (used to treat seasickness) will be used to temporarily, and safely, mimic signs of very early disease during just the first day of testing. This is a methodological study to determine if tests that measure how you think can predict the risk of dementia as we age.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01841905
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Peter J. Snyder, Ph.D.||Sr. Vice President & Chief Research Officer, Lifespan|